Rheumatoid Arthritis: U.S. Physician and Payer Perspectives on the Opportunity for Novel Oral Kinase Inhibitors, Newer Formulations of Established Biologics, Novel Biologics, and Biosimilars

Introduction:

The entrenched positioning of biologics (in particular, tumor necrosis factor-alpha [TNF-α] inhibitors) to treat moderate-to-severe rheumatoid arthritis (RA) has generated a multi-billion-dollar market. Bristol-Myers Squibb’s selective costimulation modulator Orencia, Roche/Biogen Idec/Chugai/Zenyaku Kogyo’s B-cell inhibitor Rituxan (Roche’s MabThera), and the interleukin-6 (IL-6) inhibitor Actemra/RoActemra from Roche/Chugai largely compete for TNF-refractory patients. In 2011, a subcutaneous formulation of Orencia launched, making it the first of these three non-TNF-alpha inhibitor biologics to offer the convenience of self-injection, and in November 2012, Pfizer/Takeda’s oral janus kinase inhibitor, Xeljanz (tofacitinib), was approved. Xeljanz’s convenience (twice daily oral) and efficacy profile, which is similar, on several key outcome criteria, to that of biologics, makes it a compelling option for RA patients, although it does possess a black-box warning, as do many biologics, for its risk of serious infection and malignancy. Looking forward, a subcutaneous formulation of Actemra and an intravenous formulation of the TNF-α inhibitor Simponi (from Centocor Ortho Biotech/Merck/Mitsubishi Tanabe/Janssen) are set to launch over the next year. Biosimilar versions of Janssen Biotech’s Remicade (infliximab) and Rituxan are predicted to launch in 2016. Thus, competition in this market will become increasingly fierce.

Questions Answered in This Report:

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Assess the cost control measures physicians and RA patients most frequently encounter for each biologic agent. What percentage of candidates for treatment with biologics do not receive biological treatment for cost-, safety-, and coverage-related reasons? What step therapy requirements are most commonly employed for each RA biologic, according to surveyed physicians and payers?

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Explore how treatment rates with biologics and prescribing by line differs in Medicare versus non-Medicare populations. What percentage of Medicare versus non-Medicare beneficiaries move to biological therapy? How do physicians typically prescribe biologics, by line of therapy, in Medicare and non-Medicare patients?

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Evaluate physician and payer perceptions of the new oral Jak inhibitor, Xeljanz. To what extent are physicians willing to prescribe a novel oral kinase inhibitor and non-TNF-α-inhibitor biologics in place of commonly used first- and second-line biologics? What step therapy requirements are payers demanding for Xeljanz? What step therapy requirements will exist in the future? In which lines of therapy are physicians most likely to prescribe a kinase inhibitor?
Assess physician and payer perceptions of Xeljanz’s effect on inhibiting/slowing structural damage. What percentage of surveyed rheumatologists believe that Xeljanz offers a clinically meaningful effect on structural damage progression based on a summary of trial results and their use of the new drug in clinical practice thus far? How important is structural progression data for payers today and in the future? Will payers demand this data in exchange for reimbursement of future agents?

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Explore the most likely changes to the treatment algorithm after the launch of subcutaneous non-TNF-α-inhibitor biologics (SC Actemra and IV Simponi) and biosimilar infliximab and rituximab. How will patient share shift within the TNF-α inhibitor class due to the new formulation of IV Simponi? What payer barriers limit access to the newer TNF-α inhibitors? How will IV Actemra and existing non-TNF-α inhibitors be affected by the new SC formulation? Will biosimilars cannibalize the majority of Remicade and Rituxan branded patients due to the lower cost? Will payers impose step therapy requirements and favor biosimilars over branded agents?

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Determine how physicians will prescribe Actemra and Orencia in 2016. What have been the main factors restricting physicians’ use of these drugs? How will recent data from head-to-head trials comparing each agent with Humira change physicians’ prescription and payer restrictions of these drugs? Which drug will rheumatologists prefer among all non-TNF-α-inhibitor biologics by 2016? To what extent will the launches of subcutaneous formulations of Orencia and Actemra result in greater use of each agent?

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Understand the perceived unmet need for additional RA biologics. Are physicians and payers enthusiastic about additional RA biologics? Which currently marketed biologics do surveyed physicians foresee as potentially being direct competitors with Eli Lilly/Incyte’s once daily oral kinase inhibitor baricitinib, Sanofi/Regeneron’s IL-6 inhibitor sarilumab, Novartis’s IL-17 inhibitor secukinumab, and Janssen/GlaxoSmithKline’s IL-6 inhibitor sirukumab, if further data for these agents are positive? What hurdles may they face in reimbursement, according to surveyed payers?